Trial · NCT00988208
Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer
NCT00988208, Phase 3, Completed, Celgene; results first posted 2013-09-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer. Trials, record NCT00988208. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00988208
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer
- NCT number
- NCT00988208
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,059 participants, actual
- Lead sponsor
- Celgene
- Conditions
- Prostate Cancer
- Interventions
- Lenalidomide, Docetaxel, Prednisone, Placebo
- First posted
- 2009-10-02
- Last updated
- 2018-04-04
- Other registries' IDs
- eudract:2008-007969-23
- Results first posted
- 2013-09-05
- Limitations and caveats
The independent DMC concluded that it was unlikely the trial would achieve its primary endpoint of improved overall survival. The sponsor agreed and the experimental lenalidomide/placebo treatment arm of the study was discontinued.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From randomization until death from any cause up to the cut-off date of 13 January 2012; up to approximately 26 months | Overall survival (OS) was the time from the date of randomization to the date of death from any cause. If no death was reported for a participant before the cut-off date for OS analysis, OS was censored at the last date at which the participant was alive. The median OS was calculated based on Kaplan-Meier estimates and corresponding 95% confidence interval (CI) was calculated using the method provided by Brookmeyer and Crowley. |
| Secondary | Progression-Free Survival (PFS) | From randomization until disease progression or death from any cause; up to the cut-off date of 13 Jan 2012; maximum time on study was approximately 26 months | PFS was the time from randomization to disease progression, or death, whatever occurred first. Progression criteria was met by analysis of target and non-target lesions as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters while on study or the appearance of one or more new lesions; an increase of at least 5mm as a total sum. Lymph nodes identified as target lesions (≥ 15 mm diameter in short axis) will be followed and reported by changes in diameter of short axis; or the unequivocal progression of a non-target lesion defined as an increase in the overall disease burden based on the change in non-measurable disease that is comparable in scope to the increase required to declare PD for measurable disease; Two or more new bone lesions as detected by bone scan |
| Secondary | Percentage of Participants With an Objective Response According to Response Evaluation Criteria in Solid Tumors - RECIST Version 1.1 Criteria | From day 1 to data cut-off 13 January 2012; maximum time on study was approximately 26 months | Objective response (OR) is defined as having complete response (CR) or partial response (PR) as best overall response based on RECIST Criteria 1.1 and defines a CR = Disappearance of all target lesions except lymph nodes (LN); LN must have a decrease in the short axis to \<10mm; PR = 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters; Progressed Disease (PD) = 20% increase in sum of diameters of target lesions taking as a reference the smallest sum of diameters and an absolute increase of ≥5 mm; the appearance of ≥1 new lesions; Stable Disease (SD)= Neither shrinkage to qualify for PR nor increase to qualify for PD taking the smallest sum diameters on study as reference. For non-target lesions a CR = Disappearance of all non-target lesions and all LN must be non-pathological in size \<10 mm; Non-CR/Non PD: persistence of one or more non-target lesions; PD = unequivocal progression of existing non-target lesions or appearance of new ones |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs) | From the time from of first dose of study drug administration to 28 days after the last dose of study drug and up to the data cut off date of 13 January 2012; the maximum duration of study drug was 93 weeks for DP and 90.6 weeks for DPL | A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. A TESAE is defined as any serious adverse event (SAE) occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal; |
| Secondary | Percentage of Participants Who Received Post-Study Therapies | The date when the first consent form was signed to the last date of AE data collection;up to 5 years; up to the date of the final data analysis date of 20 April 2017 | Percentage of Participants Who Received Post-Study Therapies for advanced Prostate Cancer. |
| Secondary | Percentage of Participants With Secondary Primary Malignancies During the Course of the Trial | The date when the first consent form was signed to the last date of AE data collection; up to the date of the final data analysis date of 30 November 2016; 7 years and 19 days | Second primary malignancies were monitored as events of interest and reported as serious adverse events throughout the course of the trial. |
| Secondary | Time to Onset of Secondary Primary Malignancies | The date when the first consent form was signed to the last date of AE data collection; up to the date of the final data analysis date of 30 November 2016; 7 years and 19 days | Time of Onset of Secondary Primary Malignancies was considered an event of interest |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From randomization until death from any cause up to the cut-off date of 13 January 2012; up to approximately 26 months | Intent-to-Treat (ITT) population defined as all randomized patients irrespective of whether they received treatment or not. | weeks | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | From randomization until disease progression or death from any cause; up to the cut-off date of 13 Jan 2012; maximum time on study was approximately 26 months | Based on the Intent to treat population (ITT), defined as all randomized patients irrespective of whether they received treatment or not. | Weeks | MEDIAN |
| SECONDARY | Percentage of Participants With an Objective Response According to Response Evaluation Criteria in Solid Tumors - RECIST Version 1.1 Criteria | From day 1 to data cut-off 13 January 2012; maximum time on study was approximately 26 months | Based on the ITT population | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (AEs) | From the time from of first dose of study drug administration to 28 days after the last dose of study drug and up to the data cut off date of 13 January 2012; the maximum duration of study drug was 93 weeks for DP and 90.6 weeks for DPL | The Safety Population is defined as all randomized participants who receive at least one dose of the study treatment (lenalidomide/placebo, Docetaxel, or Prednisone). | participants | NUMBER |
| SECONDARY | Percentage of Participants Who Received Post-Study Therapies | The date when the first consent form was signed to the last date of AE data collection;up to 5 years; up to the date of the final data analysis date of 20 April 2017 | The Safety Population is defined as all randomized participants who receive at least one dose of the study treatment (lenalidomide/placebo, Docetaxel, or Prednisone). | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Secondary Primary Malignancies During the Course of the Trial | The date when the first consent form was signed to the last date of AE data collection; up to the date of the final data analysis date of 30 November 2016; 7 years and 19 days | The Safety Population is defined as all randomized participants who receive at least one dose of the study treatment lenalidomide/placebo, Docetaxel, or Prednisone). | percentage of participants | NUMBER |
| SECONDARY | Time to Onset of Secondary Primary Malignancies | The date when the first consent form was signed to the last date of AE data collection; up to the date of the final data analysis date of 30 November 2016; 7 years and 19 days | The Safety Population is defined as all randomized participants who receive at least one dose of the study treatment (lenalidomide/placebo, Docetaxel, or Prednisone). | months | MEDIAN |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Docetaxel/Prednisone/Placebo (DP) | NA | 95% Confidence Interval 75.71 to NA | weeks | |
| Overall Survival (OS) | Docetaxel/Prednisone/Lenalidomide (DPL) | 77 | 95% Confidence Interval 64.29 to 81.71 | weeks | |
| Progression-Free Survival (PFS) | Docetaxel/Prednisone/Placebo (DP) | 46 | 95% Confidence Interval 42.14 to 53.57 | Weeks | |
| Progression-Free Survival (PFS) | Docetaxel/Prednisone/Lenalidomide (DPL) | 45 | 95% Confidence Interval 38.0 to 46.14 | Weeks | |
| Percentage of Participants With an Objective Response According to Response Evaluation Criteria in Solid Tumors - RECIST Version 1.1 Criteria | Docetaxel/Prednisone/Placebo (DP) | 24.3 | percentage of participants | ||
| Percentage of Participants With an Objective Response According to Response Evaluation Criteria in Solid Tumors - RECIST Version 1.1 Criteria | Docetaxel/Prednisone/Lenalidomide (DPL) | 22.1 | percentage of participants | ||
| Number of Participants With Treatment Emergent Adverse Events (AEs) | Docetaxel/Prednisone/Placebo (DP) | Any TEAE | 512 | participants | |
| Number of Participants With Treatment Emergent Adverse Events (AEs) | Docetaxel/Prednisone/Lenalidomide (DPL) | Any TEAE | 517 | participants | |
| Number of Participants With Treatment Emergent Adverse Events (AEs) | Docetaxel/Prednisone/Placebo (DP) | Any TEAE related to lenalidomide or placebo | 379 | participants | |
| Number of Participants With Treatment Emergent Adverse Events (AEs) | Docetaxel/Prednisone/Lenalidomide (DPL) | Any TEAE related to lenalidomide or placebo | 412 | participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Docetaxel/Prednisone/Placebo (DP) | 526 | |
| Overall Study | STARTED | Docetaxel/Prednisone/Lenalidomide (DPL) | 533 | |
| Overall Study | Treated | Docetaxel/Prednisone/Placebo (DP) | 521 | |
| Overall Study | Treated | Docetaxel/Prednisone/Lenalidomide (DPL) | 525 | |
| Overall Study | COMPLETED | Docetaxel/Prednisone/Placebo (DP) | 95 | |
| Overall Study | COMPLETED | Docetaxel/Prednisone/Lenalidomide (DPL) | 95 | |
| Overall Study | NOT COMPLETED | Docetaxel/Prednisone/Placebo (DP) | 431 | |
| Overall Study | NOT COMPLETED | Docetaxel/Prednisone/Lenalidomide (DPL) | 438 |
Source ClinicalTrials.gov
Adverse events684
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Docetaxel/Prednisone/Lenalidomide (DPL) | 154 | 525 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Docetaxel/ Prednisone/and Placebo (DP) | 94 | 521 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Docetaxel/Prednisone/Lenalidomide (DPL) | 40 | 525 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Docetaxel/ Prednisone/and Placebo (DP) | 34 | 521 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Docetaxel/Prednisone/Lenalidomide (DPL) | 125 | 525 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Docetaxel/ Prednisone/and Placebo (DP) | 94 | 521 | |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Docetaxel/Prednisone/Lenalidomide (DPL) | 39 | 525 | |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Docetaxel/ Prednisone/and Placebo (DP) | 18 | 521 | |
| other | LACRIMATION INCREASED | Eye disorders | Docetaxel/Prednisone/Lenalidomide (DPL) | 53 | 525 | |
| other | LACRIMATION INCREASED | Eye disorders | Docetaxel/ Prednisone/and Placebo (DP) | 63 | 521 |
1 to 10 of 684Source ClinicalTrials.gov
See all 684 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Docetaxel/Prednisone/Lenalidomide (DPL) | ||
| Total, all-cause mortality | Docetaxel/ Prednisone/and Placebo (DP) | ||
| Total, other adverse events | Docetaxel/Prednisone/Lenalidomide (DPL) | 513 | 525 |
| Total, other adverse events | Docetaxel/ Prednisone/and Placebo (DP) | 511 | 521 |
| Total, serious adverse events | Docetaxel/Prednisone/Lenalidomide (DPL) | 283 | 525 |
| Total, serious adverse events | Docetaxel/ Prednisone/and Placebo (DP) | 176 | 521 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Docetaxel/Prednisone/Lenalidomide (DPL) vs Docetaxel/ Prednisone/and Placebo (DP): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00988208
GET https://conductscience.org/api/trials/v1/NCT00988208/results?page=2